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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.176 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
26.43 mg/m³
Explanation for the modification of the dose descriptor starting point:

Derivation of an inhalation DNELsystemic long-term for a worker population

A) selection of relevant dose-descriptor(s) for the endpoint concerned

The lowest NOAEL was 30 mg/kg bw/day for developmental toxicity and this value may be taken as the definitive end point for the derivation of the DNEL for workers.

B) modification, when necessary, of relevant dose descriptor(s) per endpoint to the correct starting point (i.e., correct the unit of exposure) as described in Chapter R.8, Figure R. 8-3, conversion of an oral rat NOAEL into a corrected inhalatory NOAEC for workers.

NOAEL rat = 30 mg/kg bw/day

30 * 1/0.38 * 1/2(a)*6.7/10

30*2.63*0.5*0.67 = 26.43 mg/m3

NOAEC worker (8h) – 26.43 mg/m3

(a) Chapter R.8 page 19,In the absence of these data for both the starting route and the end route (the route to which the extrapolation is being made), worst case assumptions have to be made. Worst case in this context will be obtained assuming a limited absorption for the starting route, leading to a low (conservative) internal NOAEL. To secure a conservative external NOAEL a maximum absorption should there after be assumed for the end route, leading to a low external NOAEL. It is proposed, thus, in the absence of route-specific information on the starting route, to include a default factor of 2 (i.e. the absorption percentage for the starting route is half that of the end route) in the case of oral-to inhalation extrapolation.

C) application, when necessary, of assessment factors to the correct starting point to obtain endpoint-specific DNEL(s) for the relevant exposure pattern (duration, frequency, route and exposed human population) (see Section R.8.4)

AF to be used

Interspecies (toxicokinetics(a) x toxicodynamics(b)) = not required

Intraspecies for workers(c)= 5

Duration of exposure(d)= 6

Dose-response relationship factor(e)= 5

Quality of whole database(f)= 1

Total AF = 150

Inhalation DNELsystemic long-termfor workers = 26.43/150 = 0.176 mg/m3

(a&b)Interspecies (toxicokinetics(a) x toxicodynamics(b)) = not required

(c) R.8.4.3.1. page 28, default assessment factor of 5 for workers

(d)R.8.4.3.1. page 29, NOAEL is from a sub-acute study

(e)R.8.4.3.1. page 133, the starting point for the DNEL is a NOAEL from an OECD 422 study with a reproduction toxicity endpoint

(f)R.8.4.3.1. page 31, 1 is the default factor to be applied to a good quality database taking into account data requirements for the tonnage band.

AF for dose response relationship:
5
Justification:
R.8.4.3.1. page 133, the starting point for the DNEL is a NOAEL from an OECD 422 study with a reproduction toxicity endpoint
AF for differences in duration of exposure:
6
Justification:
R.8.4.3.1. page 29, NOAEL is from a sub-acute study
AF for interspecies differences (allometric scaling):
1
Justification:
Not required according to the REACH Chapter R. 8. This is already taken into account when the oral NOAEL is converted into an inhalatory NOAEC (modificatoin of a starting point)
AF for other interspecies differences:
5
Justification:
R.8.4.3.1. page 28, default assessment factor of 5 for workers
AF for intraspecies differences:
1
Justification:
Not required according to the REACH Chapter R. 8. This is already taken into account when the oral NOAEL is converted into an inhalatory NOAEC (modificatoin of a starting point)
AF for the quality of the whole database:
1
Justification:
R.8.4.3.1. page 31, 1 is the default factor to be applied to a good quality database taking into account data requirements for the tonnage band.
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.176 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.02 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 500
Dose descriptor starting point:
NOAEL
AF for dose response relationship:
5
Justification:
R.8.4.3.1. page 133, the starting point for the DNEL is a NOAEL from an OECD 422 study with a reproduction toxicity endpoint
AF for differences in duration of exposure:
6
Justification:
NOAEL is from a sub-acute study
AF for interspecies differences (allometric scaling):
4
Justification:
Table R.8-3, allometric scaling for Rat
AF for other interspecies differences:
2.5
Justification:
R.8.4.3.1. page 24, Interspecies difference 2.5 ‘for remaining differences’
AF for intraspecies differences:
5
Justification:
R.8.4.3.1. page 28, default assessment factor of 5 for workers
AF for the quality of the whole database:
1
Justification:
R.8.4.3.1. page 31, 1 is the default factor to be applied to a good quality database taking into account data requirements for the tonnage band.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.02 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 500
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

DNELs for local effects have not been established for AD 1 as the DNEL for systemic effects and the risk mitigation measures identified in the exposure scenarios will also be protective of local effects exposure.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

DNELs for the general population have not been derived.

AD 1 is imported into the EU and is a processing aid in a surface modification process. AD 1 is a VOC that is oxidized in an industrial oxidizer after use as a processing aid. It is not present in the finished ePTFE film.

Formulation is an industrial/professional task and therefore only worker DNELS for exposure by the dermal and inhalation routes will be derived. There will be no exposure to AD 1 for the general population.